Human Leukocyte Antigens (HLA)NCT01285427

Clinical Protocol SeCore, uTYPE and 3500 Dx System

An observational study of Human Leukocyte Antigens (HLA), run by Life Technologies Corporation.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to compare the Invitrogen SeCore(R) sequencing system and uTYPE(R) interpretation software to the predicate device Invitrogen SSP UniTray(R) with UniMatch(R) interpretation software and show 95% concordance with 90% confidence. Read more about this study

Who is it for?: Any age
Conditions the study is for: Human Leukocyte Antigens (HLA)
How many people: 300 participants
Where: No sites listed yet
Study dates: Jan 2011to Jun 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: A, B, C, DRB1, DRB3/4/5, DQB1, DPB1 loci

Who may be able to join

Deidentified leftover blood samples

Who cannot join

None listed.

About this study

Official title: SeCore Sequencing Kit and 3500xl Dx Genetic Analyzer Clinical Performance Testing vs. SSP UniTray

Read the detailed description

Testing will be performed on A, B, C, DRB1, DRB3/4/5, DQB1, and DPB1 loci. Additionally, testing will be performed using the following locus specific Group Specific Sequencing Primers: A, B, Cw, DPB1, DQB1 and DRB.

Conditions: Human Leukocyte Antigens (HLA)
Keywords: DNA, sequencing, Identification and definition of Class I and II Human Leukocyte Antigens (HLA)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01285427
Study group	Role	What they receive
DNA loci (SeCore vs. SSP UniTray platforms)		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI)
All kits,the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method
Measured: 10 weeks
SeCore® Kit, A Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)
SeCore Kit, A Locus,the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method
Measured: 10 weeks
SeCore® Kit, B Locus (Single Amp), Primary Analysis of Concordance Rate (Clopper-Pearson CI)
SeCore® Kit, B Locus (Single Amp), The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method.
Measured: 10 weeks
SeCore® Kit, C Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)
SeCore® Kit, C Locus, the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method.
Measured: 10 weeks
SeCore® Kit, DPB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)
SeCore® DPB1 Locus, the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method
Measured: 10 weeks
SeCore® Kit, DQB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)
the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method
Measured: 10 weeks
SeCore® Kit, DRB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)
The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method
Measured: 10 weeks
SeCore® Kit, DR Group Kit (DRB1 Locus), Primary Analysis of Concordance Rate (CI)
The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method
Measured: 10 weeks
SeCore® Kit, DR Group Kit (DRB345 Loci), Primary Analysis of Concordance Rate Clopper-Pearson CI)
The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method
Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Jun 2011

First posted28 Jan 2011 (estimated)
Study startJan 2011
Primary completionJun 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Human Leukocyte Antigens (HLA)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01285427
Sponsor's protocol ID: DMR0000279
Status last verified: Apr 2014
First submitted: 12 Jan 2011
Last updated: 17 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1
A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation
Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 2
Early Human Leukocyte Antigen (HLA) Matched Sibling Hematopoietic Stem Cell Transplantation
Sickle Cell Disease
RecruitingPhase 1
TLI, TBI, ATG & Hematopoietic Stem Cell Transplantation and Recipient T Regs Therapy in Living Donor Kidney Transplantation
Living Donor Kidney Transplantation
RecruitingPhase 2
Intensity Modulated Total Marrow Irradiation in Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients With High-Risk Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), and Myelodysplastic Syndrome (MDS)
Acute Myeloid Leukemia, Relapsed, Adult, Acute Myeloid Leukemia Refractory
RecruitingPhase 1
Human Leukocyte Antigen (HLA) Mismatched Unrelated Allogeneic Hematopoietic Stem Cell Transplantation
Hematologic Disease

All Human Leukocyte Antigens (HLA) trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SeCore Sequencing Kit and 3500xl Dx Genetic Analyzer Clinical Performance Testing vs. SSP UniTray
ClinicalTrials.gov ID: NCT01285427
Acronym / sponsor ID: DMR0000279
Conditions: Human Leukocyte Antigens (HLA)
Keywords: DNA, sequencing, Identification and definition of Class I and II Human Leukocyte Antigens (HLA)
Study type: Observational
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Life Technologies CorporationIndustry (pharma, biotech, devices)
Study start: Jan 2011
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 28 Jan 2011 (estimated)
Results: Posted 17 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Number of arms: 1

Arm	Type	Receives
DNA loci (SeCore vs. SSP UniTray platforms)	–	–

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: A, B, C, DRB1, DRB3/4/5, DQB1, DPB1 loci

Key inclusion criteria (1 listed)

Deidentified leftover blood samples

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI)
Time frame: 10 weeks
All kits,the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method
SeCore® Kit, A Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)
Time frame: 10 weeks
SeCore Kit, A Locus,the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method
SeCore® Kit, B Locus (Single Amp), Primary Analysis of Concordance Rate (Clopper-Pearson CI)
Time frame: 10 weeks
SeCore® Kit, B Locus (Single Amp), The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method.
SeCore® Kit, C Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)
Time frame: 10 weeks
SeCore® Kit, C Locus, the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method.
SeCore® Kit, DPB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)
Time frame: 10 weeks
SeCore® DPB1 Locus, the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method
SeCore® Kit, DQB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)
Time frame: 10 weeks
the concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method
SeCore® Kit, DRB1 Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)
Time frame: 10 weeks
The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method
SeCore® Kit, DR Group Kit (DRB1 Locus), Primary Analysis of Concordance Rate (CI)
Time frame: 10 weeks
The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method
SeCore® Kit, DR Group Kit (DRB345 Loci), Primary Analysis of Concordance Rate Clopper-Pearson CI)
Time frame: 10 weeks
The concordance rate was calculated and the corresponding exact two-sided 90% confidence interval was calculated by the Clopper-Pearson method

Results and safety

Results posted to the registry on 17 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DNA Loci (SeCore vs. SSP UniTray Platforms)	300	299

Primary outcome: All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI)

Time frame: 10 weeks. Number (90% Confidence Interval). Unit: percentage of concordant alleles

Measure	Concordance n = 299
Value	99.6 (99.29 to 99.77)

Primary outcome: SeCore® Kit, A Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)

Time frame: 10 weeks. Number (90% Confidence Interval). Unit: percentage of concordant alleles

Measure	Concordance n = 299
Value	100.0 (99.01 to 100.0)

Primary outcome: SeCore® Kit, B Locus (Single Amp), Primary Analysis of Concordance Rate (Clopper-Pearson CI)

Time frame: 10 weeks. Number (90% Confidence Interval). Unit: percentage of concordant alleles

Measure	SeCore® Kit, B Locus (Single Amp) n = 299
Value	99.7 (98.43 to 99.98)

Primary outcome: SeCore® Kit, C Locus, Primary Analysis of Concordance Rate (Clopper-Pearson CI)

Time frame: 10 weeks. Number (90% Confidence Interval). Unit: percentage of concordant alleles

Measure	SeCore® Kit, C Locus n = 299
Value	99.7 (98.43 to 99.98)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Concordance	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Human Leukocyte Antigens (HLA)

RecruitingPhase 1
A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation
Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 2
Early Human Leukocyte Antigen (HLA) Matched Sibling Hematopoietic Stem Cell Transplantation
Sickle Cell Disease
RecruitingPhase 1
TLI, TBI, ATG & Hematopoietic Stem Cell Transplantation and Recipient T Regs Therapy in Living Donor Kidney Transplantation
Living Donor Kidney Transplantation
RecruitingPhase 2
Intensity Modulated Total Marrow Irradiation in Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients With High-Risk Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), and Myelodysplastic Syndrome (MDS)
Acute Myeloid Leukemia, Relapsed, Adult, Acute Myeloid Leukemia Refractory
RecruitingPhase 1
Human Leukocyte Antigen (HLA) Mismatched Unrelated Allogeneic Hematopoietic Stem Cell Transplantation
Hematologic Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Deanna Vella study chair

Life Technologies

Questions about this trial

What is this clinical trial studying?

An observational study of Human Leukocyte Antigens (HLA), run by Life Technologies Corporation.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All SeCore® Kits,Primary Analysis of Concordance Rate (Clopper-Pearson CI) (time frame: 10 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01285427.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2014.